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Nascobal

These highlights do not include all the information needed to use NASCOBAL NASAL SPRAY safely and effectively. See full prescribing information for NASCOBAL NASAL SPRAY. NASCOBAL (cyanocobalamin nasal spray)Initial U.S. Approval: 1942

Approved
Approval ID

697e0e52-c01b-4b53-9994-f79c46eb6b4f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 30, 2018

Manufacturers
FDA

Par Pharmaceutical, Inc.

DUNS: 092733690

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

cyanocobalamin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49884-270
Application NumberNDA021642
Product Classification
M
Marketing Category
C73594
G
Generic Name
cyanocobalamin
Product Specifications
Route of AdministrationNASAL
Effective DateOctober 3, 2022
FDA Product Classification

INGREDIENTS (5)

CYANOCOBALAMINActive
Quantity: 500 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT

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